Co-Director of the Opioid Policy Research Collaborative at the Heller School for Social Policy and Management at Brandeis University

Zohydro: The FDA-Approved Prescription for Addiction

02/26/2014 12:05 am ETUpdated
Apr 27, 2014

In a few weeks, a powerful new opioid painkiller called Zohydro is expected to hit the market. Zohydro's easily crushed capsules will contain up to 50 milligrams of pure hydrocodone; that's 10 times more hydrocodone than a regular Vicodin. One capsule will pack enough hydrocodone to kill a child. An adult lacking a tolerance to opioids could overdose from taking just two capsules.

Many folks on the front line of our nation's opioid-addiction epidemic were shocked that the FDA approved Zohydro despite the strong objection of an FDA advisory committee, which voted 11-to-2 against it. This may be the first time in history that the FDA will allow a drug to be released despite a landslide vote to keep it off the market.

Concerned about FDA approval of Zohydro? You are in good company. This morning a letter signed by more than 40 organizations was sent to FDA Commissioner Hamburg, urging her to keep Zohydro off the market. The organizations include some of the most prominent addiction-treatment agencies in the country, including Hazelden, Caron, and Phoenix House. Other co-signers include CASAColumbia, the American Society of Addiction Medicine, Blue Cross Blue Shield, the consumer advocacy group Public Citizen, and dozens of community-based addiction-prevention organizations.

Understandably, concerns about Zohydro have focused on the fact that, like the original version of OxyContin, it can be easily crushed -- a feature that makes it especially lethal. But there are other good reasons to be concerned about Zohydro. It isn't just bad for so-called "abusers" who crush the capsules; Zohydro's risks will also outweigh benefits when swallowed whole by the chronic-pain patients Zohydro's maker is targeting.

Opioids are excellent medications for easing suffering at the end of life. They are also effective when prescribed short-term to treat severe acute pain. But they don't work well when taken on a daily basis for months and years. Over time, many people develop tolerance to the analgesic effects, leading them to require higher and higher doses. As the doses go up, quality of life and ability to function often declines. They can even make pain worse, as seen in a phenomenon called hyperalgesia.

At the FDA advisory meeting, several members of the committee raised concerns about the company's plan to market Zohydro for chronic pain. Before the final vote, Dr. Jevtovic-Todorovic, a member of the advisory panel, stated:

I'm an anesthesiologist, and I've been practicing in this field for quite a long time. When you talk to pain specialists in our field, they will all tell you one indisputable fact: Opiates are lousy drugs to treat chronic pain.

Dr. Jevtovic-Todorovic is absolutely right. Over the past few years, many pain specialists have been speaking out against use of long-term opioids for common problems like lower-back pain, fibromyalgia, and chronic headache.

There is another very obvious reason -- also pointed out by the advisory committee -- that it is a bad idea to take high doses of opioids on a long-term basis. Opioids, which include heroin, are highly addictive. Even if Zohydro's maker agreed to make the capsules more difficult to crush, we would still need to worry about addiction. After all, swallowing painkillers whole doesn't make them less addictive. I've been treating opioid addiction for more than a decade, and I've never once treated a patient whose painkiller addiction began with snorting or injecting opioids. Their addiction always began with swallowing whole pills. Some eventually switched to snorting or injecting after they became addicted, but most of my patients were still swallowing pills when they finally sought treatment. Making a pill abuse-deterrent doesn't make it less addictive.

According to the CDC, the overprescribing of opioids -- especially for chronic non-cancer pain -- was the main cause of our nation's opioid-addiction epidemic. When faced with this public-health crisis, the very last thing we need are new opioids released on the market with campaigns to encourage more prescribing.

If you are feeling frustrated by the FDA's decision to approve Zohydro, a drug that will surely worsen an already severe opioid-addiction epidemic, I have a couple of suggestions.

First, please call your United States senator's office and let the staff member on the phone know how you feel about the release of Zohydro. You should also ask him or her for a Senate investigation of the FDA's decision to approve the drug.

Second, please make your way to Washington, D.C., for the FED UP! rally on Sept. 28, 2014, where you will be joined by thousands of people who are equally fed up by the FDA's long track record of putting opioid manufacturers' interests ahead of public health.

I'm not optimistic about our chances of keeping Zohydro off the market. But with a Senate investigation and a large turnout at the September FED UP! rally, we may be able to keep the next Zohydro-like opioid off the market. And we can finally hold FDA leadership accountable for more than a decade of disastrous opioid policies.